|
Betamethasone Valerate Usp
5. RESULTS OF ANYALYSIS (As per IP)
Description : White Powder.
Solubility : Complies.
Identification : Complies.
A.&.B.
Specific optical
Rotation : +79.60. (Betn. +75 and +82)
Related foreign steroid : Complies by TLC
Residue on ignition : 0.04% (N.M.T.0.1%)
Loss on drying : 0.310% (N.M.T.0.5%)
Chromatographic purity : Complies. Single impurity 0.30% (NMT 1%)
BY HPLC : total impurity 0.30% (NMT 2%)
Assay(on dried basis) : 99.20% (Betn. 96 and 102% by)
Organic Voletile Impurity : 0.020.%
6. OPINION : The sample submitted with the
Prescribed standards of USP quality in above respects
7. REMARKS :
In the opinion of the undersign the sample referred to above IS OF STANDARD QUALITY
The sample complies with above standard as per USP.
|
